Homeopathy in Cancer Care

Moshe
Frenkel, MD, is an associate professor at the University of Texas,
Houston, and former medical director of the Integrative Medicine
Program, The University of Texas MD Anderson Cancer Center, Houston.

Homeopathy
is a controversial system of care that is practiced extensively in
Europe, Asia, and South America primarily for functional and minor
ailments. In this review, published studies on homeopathic remedies and
cancer were examined. Data were obtained from multiple research
disciplines, ranging from basic science to scientifically valid animal
and clinical studies. The data from a few laboratory experiments in
cancer models show some beneficial effect of homeopathic remedies on
selected cancer cell lines. However, in the clinical arena, this effect
is not clear. Several published outcome studies and some randomized
controlled trials have shown that there may be a role for homeopathy in
symptom relief and improving quality of life in patients touched by
cancer. Such effects have not been demonstratedunequivocally, and
specific antitumor effects have not been shown in any controlled
clinical research to date, which raises the need for further clinical
trials to investigate the use of homeopathy in cancer care. (Altern Ther
Health Med.2010;16(3):12-16.)

Homeopathy is a form of health
care that is widely practiced worldwide and is one of the main
complementary and alternative medicine (CAM) treatmentscommonly used
by patients in Europe, India, Israel, and Latin America.1-5 Even though
sales of homeopathic medicines in the United States grew at an annual
rate of 20% to 25% during the 1990s,3 this complementary method of care
did not gain the same popularity as it did in Europe, Asia, and South
America, and currently only1.8 % of CAM users in the United States
utilize it.6 Despite homeopathy’s low popularity, homeopathic medicines
in the United States are regulated by the US Food and Drug
Administration following the Homeopathic Pharmacopoeia of the United
States (HPUS) that was established in 1897 and is still updated
regularly. According to the HPUS, consumers can buy homeopathic
substances without a prescription for self-limiting diseases that are
amenable to self-diagnosis as long as the medicines do not contain toxic
substances.7 Most authorities assume that homeopathic drugs are safe as
long as conventional medical care is not delayed.3,7

Homeopathy at the Center of Controversy

Homeopathy
is a controversial method based on the “principle of similars,” whereby
highly diluted preparations of substances that can cause disease-like
symptoms in healthy volunteers are used to stimulate healing in patients
who have similar symptoms when ill.8,9 Many scientists think that the
principles underlying homeopathy violate natural law. They do not accept
that it has any biological effects and consign any positive response to
the placebo effect. The dispute centers mainly on the issue of whether
highpotency remedies (preparations diluted beyond Avogadro’s number) can
be effective. The skepticism comes from the understanding that
potencies (dilutions) of substances beyond 7C (7 dilutions, each 1:100)
do not contain a sufficient number of molecules of the original material
to be pharmacologically active.10,11 Some reports suggest that even
with high dilutions, there is clinical response that cannot be ignored.
The evidence supporting homeopathy has grown in recent years and is
supported by some scientific findings in an array of fields.6-8,12-15
Authors of a metaanalysis of 89 randomized, placebo-controlled trials of
homeopathy concluded that their results were not compatible with a
hypothesis that the clinical effects of homeopathy are completely due to
placebo.16A large prospective multicenter cohort study was recently
published, involving 103 homeopathic primary care practices in Germany
and Switzerland and 3709 patients. The patients had various conditions,
such as allergic rhinitis, headache, atopic dermatitis and multiple
recurrent infections in children. The study revealed that disease
severity decreased significantly (P < .001) between baseline and 2
and 8 years of follow-up. The authors suggested that patients who seek
homeopathic treatment are likely to improve considerably. This effect
was maintained for as long as 8 years. Because the study was not
intended to prove cause and effect, the authors were unable to conclude
if this effect was related to the homeopathic remedies themselves or to
the physicians’ attitudes and approaches to the patient.17

Homeopath y and Cancer

People
use homeopathy for a range of health concerns, from wellness and
prevention to the treatment of diseases and conditions such as
diarrhea,12 attention defficit disorder,13 allergies,14 depression,15
and others.18 But the question that comes to mind is whether this
treatment has any place in more serious situationsand
life-threatening disorders, such as cancer. It is well known that over
the past 2 decades, the use of CAM has been on the rise worldwide, and
patients with cancer are increasingly opting to be treated with various
CAM therapeutic regimens and at higher rates than the general
population.20-24In Europe, homeopathy is popular for common
ailments, as well as for cancer care. In fact, a questionnaire-based
study showed that homeopathy was one of the eight most popular
complementary therapies used by cancer patients in the United Kingdom.25
In France, a recent study in an oncology department revealed that34%
of patients were using complementary medicine and that, among those
patients, homeopathy was the most frequently used (42%).4 A recent
survey at two oncology day hospitals in Italy found that 17% of patients
used CAM, with herbal medicine and homeopathy the most commonly used
forms.5

A large descriptive survey of 956 cancer patients in 14
European countries revealed that 35.9% of cancer patients were using
some form of CAM (range among countries, 14.8% to 73.1%). Homeopathy was
the most commonly used CAM therapy in Belgium and in the top five in
six other countries (Turkey, CzechRepublic, Sweden, Italy, Spain,
and Greece). In the remaining seven countries, it was still highly used
but followed the use of herbal remedies.26Even with the popular use
of these remedies in cancer care in Europe, it is still unclear whether
homeopathy has any clinical effect, and until recently, homeopathy has
not received attention as a possible option of care. A 2008 clinical
report from India on 14 patients treated apparently effectively with
homeopathic remediesas part of a unique National Cancer Institute
(NCI) program drew the conclusion that homeopathy might have effects on
cancer care.27 Those were preliminary findings that drew attention to
the issue of homeopathy in cancer care, but it still remains to be
proven in properly designed clinical trials. This unique NCI program isbetter
known as “The Best Case Series” (BCS).NCI Best Case Series The safety
and efficacy of many CAM approaches have not been well studied,
especially in the field of cancer care. Because of this scarcity of
knowledge, the NCI has developed a program that allows CAM practitioners
to present their data for evaluation andfurther research toward
rigorous scientific validation. In the past 10 years, the NCI’s BCS
program has invited CAM practitioners from all over the world to submit
retrospective data on patients that document significant tumor reduction
in response to alternative modalities of cancer treatment. Each case
has been reviewedagainst the same rigorous standards of evidence
that are acceptable for novel conventional cancer therapies. The NCI-BCS
program offers practitioners treating cancer patients expert assistance
in identifying and compiling persuasive case studies, as well as the
opportunity to have their data evaluated at the National Institutesof
Health.28 In 1999, the NCI-BCS program evaluated the cancer treatment
protocol developed at the P. Banerji Homeopathic Research Foundation
(PBHRF) in Kolkata, India. The “Banerji Protocol” constitutes a new
method of using ultradiluted natural substances classically used in
homeopathic medicines through prescribingspecific remedies for
specific diseases. As documented by this clinic, a group of 21 888
patients with malignant tumors were monitored at PBHRF between 1990 and
2005. This group of patients used the Banerji Protocol without being
subjected to any additional method of conventional care. Of these, 941
patients had breast cancer. The clinic’s physicians reported that in 19%
of the cases, the malignant tumors completely regressed, and in another
21% of cases, the tumors were static or improved after treatment. For
patients with static tumors, the follow-up continued for at least 2
years, and for some, follow-up has continued for 10 years. (Personal
communication: conversation with Prasanta Banerji at the PBHRF in
Kolkata, 2008.) Ten cases from the PBHRF were presented to the NCI for
review by the BCS program. Four cases of lung and esophageal cancer were
found to have confirmed pathological diagnoses of cancer and adequate
pretreatment and posttreatment medical imaging studies indicating tumor
response. The patients treated with the Banerji Protocol approach
received only the remedies prescribed at the PBHRF clinic and did not
receive any additional conventional treatment such as surgery,
radiation, or chemotherapy. The remedies prescribed have been
classically used as homeopathic medicines. After rigorous evaluation of
the findings, the NCI concluded that there was sufficient evidence of
possible efficacy to warrant further research. The Office of Cancer
Complementary and Alternative Medicine of the NCI currently is working
with researchers at the All India Institute of Medical Sciences to
obtainapproval for a prospective outcomes monitoring and evaluation study at the PBHRF clinic.

Laboratory Research and Homeopathy

In
the field of cancer research, a very limited number of reports have
systematically investigated the effects of homeopathic remedies in
clinical trials or in experimental model systems. Interestingly,
however, the limited existing reports on laboratory research with
homeopathic remedies in cancer are quite promising. MacLaughlin and his
group evaluated the effect of homeopathic preparations on human prostate
cancer growth in an animal model.29 They found that, in vivo, prostate
tumor xenograft size was significantly reduced in Sabal
serrulata–treated mice compared to untreated controls (P = .012). Their
study revealed a significantly stronger biologic response to homeopathic
treatment, as manifested by cell proliferation and tumor growth, than
to control treatments. The response in the human prostate cancer was
specifically induced by S serrulata; other homeopathic remedies had no
effect. The researchers concluded that S serrulata thus should be
further investigated as a specific homeopathic remedy for prostate
pathology. A complex homeopathic remedy frequently prescribed by
Brazilian physicians for immunodeficiency disorders was tested on
sarcoma 180–bearing mice, and significant tumor regression was noted in
the treatment group.30 In another study, researchers reported that the
homeopathic remedy Chelidonium caused amelioration of
p-dimethylaminoazobenzene–induced hepatocarcinogenesis in mice.31 14

A
few studies from India indicate that homeopathic remedies at ultralow
doses may be able to decrease tumor progression. Kumar et al evaluated
the inhibitory effects of potentized homeopathic preparations against
N’-nitrosodiethylamine (NDEA)–induced hepatocellular carcinoma in rats
as well as 3-methylcholanthrene–inducedsarcomas in mice.32
Administration of the remedies retarded the tumor growth and
significantly reduced the elevated marker enzyme levels as revealed by
morphological, biochemical, and histopathological evaluation. The
specific remedies Ruta 200C and phosphorus 1M (1000C) were found to
reduce the incidence of3-methylcholanthrene–induced sarcomas and
also increase the lifespan of mice harboring the tumors. Sunila and
Kuttan evaluated the effect of Thuja occidentalis extract on the
inhibition of lung metastasis induced by melanoma cells in C57BL/6
mice.33 A remarkable reduction in tumor-nodule formation was shown,regardless
of whether the drug was given simultaneous with (74.4%) or before
(71.5%) tumor cell administration. The level of collagen hydroxyproline
(21.13 μg/mg protein) was higher in the lungs of control animals with
lung metastases than in the lungs of normal animals (0.98 μg/mg
protein); however, the level was significantlyreduced in animals
treated with the homeopathic remedy Thuja occidentalis. The lifespan of
the Thuja-treated animals also was reported to be significantly
increased.

In 2004, Pathak et al from The University of Texas MD
Anderson Cancer Center reported that an ultradiluted dose of the
homeopathic remedy called Ruta graveolens, commonly prescribed as the
standard Banerji Protocol therapeutic regimen for brain cancer,
selectively induced cell death in glioblastoma multiformecells, while promoting proliferation in normal peripheral blood lymphocytes.34

In
another interesting study that was recently published and conducted at
The University of Texas MD Anderson Cancer Center, four ultradiluted
remedies (Carcinosin, Phytolacca, Conium, and Thuja) exerted
preferential cytotoxic effects against two breast cancer cell lines,
causing cell cycle delay/arrest and apoptosis withoutaffecting the
normal mammary epithelial cells. These effects were accompanied by
altered expression of the cell cycle regulatory proteins, including
downregulation of phosphorylated Rb and upregulation of the CDK
inhibitor p27, which were likely responsible for the cell cycle
delay/arrest as well as induction of the apoptotic cascadethat
manifested in the activation of caspase 7 and cleavage of PARP in the
treated cells. Interestingly, the cytotoxic effect of two of the
remedies investigated in this study, Carcinosin and Phytolacca, appeared
similar to the activity of paclitaxel, the most commonly used
chemotherapeutic drug for breast cancer.35

Not all laboratory
studies revealed favorable results. Thangapazham et al investigated the
effect of the homeopathic medicines Conium maculatum, S serrulata, Thuja
occidentalis, Asterias, Phytolacca, and Carcinosin on prostate and
breast cancer cells. They found that none of the homeopathic remedies
tested in different potencies produced significant inhibitory or growth
promoting activity in either prostate or breast cancer cells.36
Interestingly, the same authors conducted another study inwhich they
evaluated the effects of commonly used homeopathic remedies in cell and
animal models of prostate cancer. The researchers found no effects on
cell viability or gene expression in three prostate cell lines with any
remedies at any exposure time, but there was a 23% reduction in tumor
incidence (P < .0001), andfor animals with tumors, there was a
38% reduction in tumor volume in homeopathy-treated animals vs controls
(P < .02). At time of sacrificing, experimental animals with tumors
had a 13% lower average tumor weight (P < .05). Tumors in these
treated animals showed a 19% increase in apoptotic cell death (P <
.05) and reducedPCNA-positive cells. The authors concluded that the
findings indicate that selected homeopathic remedies have no direct
cellular anticancer effects but appear to significantly slow the
progression of cancer and reduce cancer incidence and mortality in
Copenhagen rats injected with MAT-LyLu prostate cancer cells.37An
intriguing recent report by Amri et al tried to explain the molecular
mechanisms of the observed reduced tumor volume in mice that were
inoculated with human prostate cancer cells and treated with ultralow
concentrations of S serrulata. The examination of the ultrastructural
cytomorphology revealed cellular disintegrationincompatible with the
well-defined apoptosis or necrosis cell death. The analysis indicated a
novel caspase-independent cell death, which might explain the
significant tumor size reduction in the treated animals. The authors
concluded that their data suggested that these ultralow concentrations
triggered a pathway not yet characterized as cell death and not related
to classical apoptosis or necrosis.38

Clinical Research

Only
a few clinical research studies have tried to investigate homeopathy
with high-quality research designs, despite homeopathy’s widespread use.
Searches of five major scientific literature databases were conducted
in June 2005 by Ernst at the University of Exeter (UK) in collaboration
with an investigator at MD Anderson Cancer Center.39 Fifty-four
potentially relevant studies of homeopathy and cancer were identified:
12 animal or in vitro studies and 42 human studies. Only the six human
studies with a control group were selected for independent review. The
quality of each study was assessed using Jadad Criteria. The researchers
summarizedthat five of the six trials indicated that homeopathic
remedies might be effective in cancer care. However, the authors
concluded that the evidence that emerged from their review was not
convincing due to the very limited number of studies and limited quality
of the data that were available for them to evaluate.

A more
recent review of clinical trials in homeopathy and cancer was performed
by The Cochrane Collaboration.40 This review concentrated on the
effectiveness and safety of homeopathic medicines that were used to
prevent or treat adverse effects of cancer treatments. The reviewers
found eight controlled trials witha total of 664 participants. Three
were studies of adverse effects of radiotherapy, three were studies of
the effect on side effects of chemotherapy, and two were studies of the
effects on menopausal symptoms associated with breast cancer treatments.
The review found preliminary data that suggest beneficial effect of
homeopathyin dermatitis during radiotherapy- and
chemotherapy-induced stomatitis. There was no convincing evidence for
the efficacy of homeopathic remedies for other adverse effects of cancer
treatments. On the other hand, as far as the safety issue is concerned,
no serious adverse effects were related to the homeopathic remediesthat
were used. One of the controlled studies mentioned in both reviews was a
triple-blinded study (Jadad score 5) of single and combination
homeopathic remedies for women with a history of breast cancer who were
experiencing hot flashes.19 Even though the results were not positive
for the primary outcome (hot flashes), one cannotignore details that
might point to some benefit. In this study, Jacobs et al evaluated 83
breast cancer survivors. Patients who suffered from an average of three
hot flashes daily for a month before the trial were randomized into
three groups: a placebo combination and a verum single remedy, a verum
combination medicineand a verum single remedy, and two placebo
combinations. The single individually selected remedies consisted of 35
homeopathic medications, mainly Sepia, Calcarea carbonica, Sulfur,
Lachesis, and Kali carbonicum (mostly high potencies). The combination
remedy was Hyland’s Menopause (Hyland’s Inc, Los Angeles, California),
which contains Amyl nitrate, Sanguinaria canadensis, and Lachesis. A
significant improvement in general health score was observed in both
homeopathy groups as compared with the placebo group. However, those
taking the combination remedy had an increase in hot flashes and
headaches. This may have been related to the participants’taking the
combination daily for a year, in contrast to the over-the-counter
instructions that specified taking only untilsymptoms decreased or for 7 days if they did not decrease.

Kulkarni
conducted a randomized clinical trial to test the effectiveness of
homeopathy on the severity of radiotherapy-related side effects.41
Patients with different types of cancer (N = 82) were randomized into
three parallel arms receiving either placebo, Cobaltum 30C, or Causticum
30C. Patients were evaluated weeklyusing an 18-point radiation
reaction profile, and the average severity score was calculated at the
end of the study. The reaction profile scores in both experimental
groups were lower than that in the placebo group. Oberbaum tested the
effectiveness of a homeopathic remedy called Traumeel S for
chemotherapy-induced stomatitisafter allogeneic or autologous stem
cell transplantation.42 Patients (N = 30) were randomized to two groups:
the Traumeel S oral rinse or a placebo rinse. Traumeel S contains
Arnica 2X (“X” means decimal potency), Calendula 2X, Millefolium 3X,
Chamomilla 3X, Symphytum 6X, Belladonna 2X, Aconitum 2X, Bellis perennis
2X,Hypericum 2X, Echinacea angustifolia 2X, Echinacea purpurea 2X,
Hamamelis 1X, Mercurius sol, and Hepar sulfuris 6X. Significant
differences favoring the Traumeel S group were observed in terms of
reduction in the severity or duration (or both) of stomatitis and in
time to worsening of symptoms. Patients in that group showed areduction
in oral pain and discomfort, dryness of mouth and tongue, difficulty
swallowing, and dysphagia.Balzarini tested the effectiveness of
homeopathic treatmentfor skin reactions during radiotherapy for
breast cancer.43 Patients (N = 61) were randomized into groups receiving
three granules of Belladonna 7C twice daily and the homeopathic remedy X
Ray 15 C once daily or placebo. Patients treated with homeopathy noted a
decrease in skin temperature and hyperpigmentation, but thesedifferences
were no longer significant by the end of the 10-week follow-up. Total
severity scores favored homeopathy, but statistical significance for the
difference was noticed only during recovery.

Pathak and Banerji
did not conduct a randomized clinical trial, but their work is worth
mentioning, as they described 15 patients diagnosed with documented
intracranial tumors who were treated exclusively with the homeopathic
remedies Ruta 6c and Calcarea phosphorica 3X without additional
chemotherapy or radiation.34 Of these 15 patients, six of the seven who
had glioma showed complete regression of the tumors. Thompson and Reilly
described a study population of 100 consecutive patients with cancer
who had been referred to an National Health Service homeopathic hospital
for complementary therapies.44 The study evaluatedthe homeopathic
approach in relation to symptom control and its impact on mood
disturbance and quality of life. Fifty-two patients completed the study;
in those patients, satisfaction was high, and 75% (n = 38) rated the
approach as helpful or very helpful for their symptoms. Symptom scores
for fatigue and hot flashes improvedsignificantly over the study
period, but scores for pain did not. Not all clinical trials yielded
findings favorable to homeopathy. Thompson et al compared homeopathy
with placebo in 53 breast cancer survivors with estrogen-withdrawal
symptoms.45 Patients randomized to homeopathy were prescribed 71
individually selected remedies, most commonly Sulfur, Sepia,
Carcinosin,Natrum muriaticum, Belladonna, and Arnica (mostly high
potencies). No significant differences in symptom relief were notedbetween
the experimental and placebo groups. Ernst et al in two commentaries on
this issue stated that they felt that currently available randomized
clinical trials are so few in number and are so burdened with
significant limitations that there is no reason to believe that
homeopathic medicines have anything to offer to patients suffering from
cancer.11,39 They also concluded that there is no evidence at all that
homeopathic remedies can change the natural history of any cancer.
However, Ernst et al reviewed only clinical studies that describe
improvement in symptoms related to cancer therapies11,39 and did not
actually address the issue of the effect on disease progression, an
issue that Banerji raised in this NCI BCS publication. Banerji’s work,
while intriguing and interesting, has been purely observational and with
a small number of patients. This type of observation needs to be
followed by a high-quality clinical trial in order to confirm the effect
on disease progression. One also cannot ignore the findings that
are available from preclinical data and animal studies, as mentioned
above. As we can see, much headway has been made in homeopathic cancer
research in recent years. Much of this effort resides in the realm of
basic science; however, anecdotal evidence and the few clinical trialsthat
do exist raise the issue that homeopathy may be of value in cancer
care, mainly in reduction of conventional treatment side effects and
supportive care.46 In his review of the role of homeopathy in cancer
care, Paterson mentions that whether conventional practitioners like it
or not, many cancer patients will continue toturn to alternatives,
including homeopathy, in increasing numbers.47 As a result, oncologists
who are sufficiently open-minded to acknowledging the role of homeopathy
in cancer care have a challenge to collaborate in performing the
high-quality studies that are needed to determine whether homeopathy has
any benefit in treatingpatients with cancer.

In
summary, data from multiple research disciplines, ranging from studies
that evaluate the effect of homeopathic remedies on cancer cell lines to
scientifically valid animal and clinical studies, raise some clues that
necessitate further studies. Several published outcome studies and the
randomized clinical trials mentioned in this
article suggest two main results. First, the homeopathic remedies used
in the clinical trials that were mentioned appear to be safe and without
adverse effects. Second, there may be a role for homeopathy in
improving quality of life in some cancer patients. Such effects have not
been demonstrated unequivocally, and specific antitumor
effects have not been shown in any controlled clinical research to
date. However, the positive reports from the few laboratory experiments
in cancer models that are mentioned in this review are indeed
noteworthy. Appropriate clinical trials are still needed to investigate
the use of homeopathy in cancer care.